Chennai, October 4, 2025
In a decisive move to safeguard public health, the Tamil Nadu government has imposed an immediate ban on the sale, distribution, and production of 'Coldrif' cough syrup after state laboratory tests uncovered a shocking 48% contamination with diethylene glycol (DEG)—a lethal industrial solvent notorious for causing fatal kidney damage in children. The contaminated batch has been implicated in at least 11 child deaths across Madhya Pradesh and Rajasthan, reigniting fears of a repeat of the 2022 global cough syrup crisis that claimed hundreds of young lives. While the Union Health Ministry insists no toxins were found in federal tests, Tamil Nadu's rapid action has exposed potential lapses in national drug quality controls, prompting calls for a unified regulatory overhaul.
The ban, announced late Friday, targets Batch No. SR-13 of Coldrif syrup, produced in May 2025 by Sresan Pharmaceuticals in Sunguvarchathiram, Kancheepuram district, with an expiry date of April 2027. This over-the-counter medication, formulated with paracetamol, phenylephrine hydrochloride, and chlorpheniramine maleate to alleviate cold and flu symptoms, was flagged following an urgent alert from Madhya Pradesh's drugs control department on October 1. Within 24 hours, Tamil Nadu's Drugs Control Department dispatched samples to the Government Drugs Testing Laboratory in Chennai, where analysis confirmed the syrup's propylene glycol solvent was adulterated with DEG at alarmingly high levels.
S. Gurubharathi, Deputy Director of Drugs Control and Licensing Authority in Tamil Nadu, detailed the findings in a press briefing, underscoring the gravity of the discovery. "The test report unequivocally showed 48% diethylene glycol in the syrup, rendering it not of standard quality and posing an imminent risk to consumers, particularly children," Gurubharathi said. "DEG is a nephrotoxic poison that leads to acute kidney injury, metabolic acidosis, and multi-organ failure. It's not added deliberately but creeps in as an impurity during manufacturing if cheap substitutes are used for legitimate solvents." Of the five batches tested—including four other syrup variants from the same unit—only Coldrif SR-13 failed, with its active ingredients passing muster but the overall formulation deemed unsafe due to the solvent impurity.
The contamination's deadly toll has mounted rapidly. In Madhya Pradesh's Chhindwara district, nine children aged 1 to 5 succumbed over the past three weeks after exhibiting symptoms of fever, cough, vomiting, and rapid renal shutdown following ingestion of the syrup. Initial autopsies pointed to unexplained acute kidney injury, echoing DEG poisoning patterns. Two more deaths in Rajasthan's Sikar and Bharatpur districts brought the total to 11, with grieving families reporting similar unsupervised home administration of the generic syrup without pediatric consultation. As of Saturday morning, reports indicate the figure has climbed to 12, with health officials in both states scrambling to trace distribution chains.
Tamil Nadu's swift response—issuing a stop-production order, a show-cause notice for license cancellation, and directing retailers to recall all stocks—stands in stark contrast to the Centre's timeline. The state also alerted neighboring Odisha and Puducherry, where distribution records show limited shipments. "We cannot wait for federal clearances when lives are at stake," a senior Drugs Control official told reporters. "Non-compliances with Schedule M (good manufacturing practices) and Schedule L1 (complaint reporting) were evident during our facility inspection, including inadequate solvent purity checks and poor record-keeping."
However, the Union Health Ministry pushed back forcefully on Saturday, asserting that tests on 13 seized samples—including two cough syrups—from the incident sites showed no traces of DEG or ethylene glycol (EG), another common contaminant. Samples analyzed by the Madhya Pradesh State Food and Drug Administration and the National Institute of Virology (NIV) in Pune corroborated this, with one Chhindwara case testing positive for leptospirosis—a bacterial infection spread via contaminated water—rather than chemical poisoning. "Preliminary investigations rule out toxic contaminants in the cough syrups linked to these tragic deaths," the ministry stated in an official release, announcing a multi-agency probe involving the National Centre for Disease Control (NCDC), Central Drugs Standard Control Organisation (CDSCO), and Indian Council of Medical Research (ICMR).
In Rajasthan, Director of Public Health Ravi Prakash Sharma echoed the federal line: "The two children were given the cough syrup at home without medical advice. This generic formulation is not recommended for pediatric use, and our inquiry confirms no direct link to government-supplied medicines under the Chief Minister’s free scheme." The state has broadened its probe to Kayson Pharma, a supplier of free drugs, though no Coldrif connection was established.
The discrepancy has fueled political firestorms. Senior Congress leader Kamal Nath, representing Madhya Pradesh, lambasted the state BJP government for "dragging its feet" on testing. "While Tamil Nadu acted in 24 hours—testing, confirming, and banning—Madhya Pradesh is still 'awaiting reports' on brake oil-mixed syrups that killed innocents," Nath posted on X, demanding immediate accountability and compensation for affected families. Tamil Nadu Chief Minister M.K. Stalin praised his administration's vigilance, tweeting: "Public health first: Our labs don't wait for Delhi's nod when poison is detected."
Health experts warn that DEG, a sweet-tasting but odorless chemical used in antifreeze and brake fluids, is a cheap adulterant for propylene glycol in cost-cutting manufacturing. "Even low doses can be fatal in children due to their immature kidneys," said Dr. V. Ramasubramanian, a pediatric infectious disease specialist at Apollo Hospitals, Chennai. "This isn't isolated—recall the 2022 Gambia tragedy where Indian syrups with DEG killed 70 kids, leading to WHO's stricter guidelines. We need mandatory DEG testing at every batch and real-time pharmacovigilance."
In response, the Centre has issued a nationwide advisory to states and union territories, urging "rational use" of cough syrups in pediatrics. It explicitly advises against prescribing such medications to children under two, emphasizing that most viral coughs resolve without intervention. "Over-reliance on syrups exposes kids to unnecessary risks; honey and hydration suffice for mild cases," the advisory notes, while calling for enhanced monitoring of over-the-counter sales.
Sresan Pharmaceuticals, a mid-sized firm with annual turnover under ₹50 crore, has not issued a public statement as of press time. Sources indicate the company is cooperating with inspectors, claiming the contamination stemmed from a "supply chain anomaly" in raw materials. The facility remains sealed, with CDSCO teams en route for a joint audit.
This scandal underscores deeper fissures in India's ₹4 lakh crore pharmaceutical industry, which supplies 20% of global generics but grapples with quality lapses. Post-2022 reforms mandated risk-based inspections and global certificates of analysis, yet enforcement varies by state. Advocacy groups like the Patient Safety Alliance are petitioning for a national recall of all Coldrif batches and criminal probes under the Drugs and Cosmetics Act, 1940, which carries up to 10 years' imprisonment for adulteration endangering life.
As families mourn and investigators dig deeper, Tamil Nadu's ban serves as a beacon of proactive governance amid national uncertainty. Parents are urged to discard any Coldrif stocks, consult physicians for alternatives, and report side effects via the PvPI helpline (1800-180-3024). Further updates from the federal probe are anticipated by mid-week, but for now, the shadow of preventable tragedy looms large over India's medicine cabinets.
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